ContraceptionPhase 2NCT00967746
An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
A Phase 2 study testing Etonogestrel-releasing IUS and Multiload-cu 375® in people with Contraception, run by Organon and Co at 1 site in Germany.
Trial summary
This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Etonogestrel-releasing IUS and Multiload-cu 375®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects in need for contraception will be selected to participate in the trial;
- Each subject must be >=18 to <=40 years of age at screening and in need for contraception;
- Each subject must have given birth to at least one child (gestational age >=28 weeks);
- Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri.
Who cannot join
- A subject must not be pregnant or suspected to be pregnant;
- A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis;
- A subject must not have a history or presence of any malignancy;
- A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies;
- A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism);
- A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of >=3 times the upper normal limit;
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- A subject must not have congenital or acquired malformations or distortions of the uterus or cervix;
- A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator;
- A subject must not have vaginal bleeding of undiagnosed etiology;
- A subject must not have dysmenorrhea interfering with daily activities or menorrhagia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Doses of an Etonogestrel-releasing Medicated Intrauterine System (ENG-MIUS) Versus a Copper-releasing Intrauterine Device (IUD)
This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception.
The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.
- Conditions
- Contraception
- Being tested
- Etonogestrel-releasing IUS, Multiload-cu 375®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel-releasing IUSDrug
Also called SCH 900342, ORG 299001
Low dose; treatment duration of 6 months with a possible extension to 12 months
Etonogestrel-releasing IUSDrug
Also called SCH 900342, ORG 299001
Intermediate dose; treatment duration of 6 months with a possible extension to 12 months
Etonogestrel-releasing IUSDrug
Also called SCH 900342, ORG 299001
High dose; treatment duration of 6 months with a possible extension to 12 months
Multiload-cu 375®Device
Duration of 6 months with a possible extension to 12 months
| Study group | Role | What they receive |
|---|---|---|
| ENG-MIUS low | Experimental | Low dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm Receives: Drug: Etonogestrel-releasing IUS |
| ENG-MIUS intermediate | Experimental | Intermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm Receives: Drug: Etonogestrel-releasing IUS |
| ENG-MIUS high | Experimental | High dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm Receives: Drug: Etonogestrel-releasing IUS |
| Multiload | Active comparator | Multiload-cu 375® Receives: Device: Multiload-cu 375® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subject's satisfaction with the ENG-MIUS
Measured: 6 months
Secondary outcomes (1)
Vaginal bleeding pattern
Measured: Days 92 to 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967746
- Sponsor's protocol ID
- P06060
- Status last verified
- Feb 2022
- First submitted
- 27 Aug 2009
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Doses of an Etonogestrel-releasing Medicated Intrauterine System (ENG-MIUS) Versus a Copper-releasing Intrauterine Device (IUD)
- ClinicalTrials.gov ID
- NCT00967746
- Acronym / sponsor ID
- P06060
- Conditions
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception.
The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ENG-MIUS low | Experimental | Drug: Etonogestrel-releasing IUSLow dose: ENG-MIUS containing 38 mg ENG with a skin thickness of approximately 350 μm |
| ENG-MIUS intermediate | Experimental | Drug: Etonogestrel-releasing IUSIntermediate dose: ENG-MIUS containing 61 mg ENG with a skin thickness of approximately 140 μm |
| ENG-MIUS high | Experimental | Drug: Etonogestrel-releasing IUSHigh dose: ENG-MIUS containing 72 mg ENG with a skin thickness of approximately 50 μm |
| Multiload | Active comparator | Device: Multiload-cu 375®Multiload-cu 375® |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female subjects in need for contraception will be selected to participate in the trial;
- Each subject must be >=18 to <=40 years of age at screening and in need for contraception;
- Each subject must have given birth to at least one child (gestational age >=28 weeks);
- Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri.
Key exclusion criteria (10 listed)
- A subject must not be pregnant or suspected to be pregnant;
- A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis;
- A subject must not have a history or presence of any malignancy;
- A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies;
- A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etonogestrel-releasing IUSAlso: SCH 900342, ORG 299001Low dose; treatment duration of 6 months with a possible extension to 12 months | Drug | ENG-MIUS low |
| Etonogestrel-releasing IUSAlso: SCH 900342, ORG 299001Intermediate dose; treatment duration of 6 months with a possible extension to 12 months | Drug | ENG-MIUS intermediate |
| Etonogestrel-releasing IUSAlso: SCH 900342, ORG 299001High dose; treatment duration of 6 months with a possible extension to 12 months | Drug | ENG-MIUS high |
| Multiload-cu 375®Duration of 6 months with a possible extension to 12 months | Device | Multiload |
Primary outcome
The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subject's satisfaction with the ENG-MIUS
Time frame: 6 months
1 secondary outcome
Vaginal bleeding pattern
Time frame: Days 92 to 182
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etonogestrel-releasing IUS and Multiload-cu 375® in people with Contraception, run by Organon and Co at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subject's satisfaction with the ENG-MIUS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.